Title 21: Food and Drugs
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/ PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES
/ Subpart I - Hematology Reagents / § 864.8165 Calibrator for hemoglobin or hematocrit measurement.
§ 864.8165 Calibrator for hemoglobin or hematocrit measurement.
(a) Identification. A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.